FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS

MDR report key: 1973832 · Received January 18, 2011

Report

Report Number: 3004209178-2011-80163
Event Type: Injury
Date Received: January 18, 2011
Date of Event: January 6, 2011
Report Date: January 6, 2011
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS MED-REL
Product Code: MDS
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED EXPERIENCING LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE WAS FOUND BY A RELATIVE AND THE PARAMEDICS WERE CALLED. WHEN THE PARAMEDICS ARRIVED THEY COULD NOT GET HER BLOOD GLUCOSE READING, AND SHE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER WAS TREATED AND HER BLOOD GLUCOSE READING WAS 164 MG/DL. THE CUSTOMER STATED THAT THE DOCTOR WAS NOT ABLE TO DETERMINE THE REASON FOR HER LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT AFTER BEING RELEASED SHE HAD UPDATED THE BASAL RATES PER HER DOCTOR'S INSTRUCTIONS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE TESTED HER GLUCOSE LEVEL BEFORE THE LOW GLUCOSE EPISODE AND IT READ 208 MG/DL, SO SHE BOLUSED 3.0 UNITS. THE AMOUNT OF INSULIN IN THE RESERVOIR MATCHED TO THE STATUS SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS	INSULIN INFUSION PUMP	MDS	MEDTRONIC PUERTO RICO OPERATIONS MED-REL	MMT-522NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization